Roche has received FDA 510(k) clearance for the cobas BV/CV assay, a single-sample molecular test that detects bacterial vaginosis and Candida vaginitis from a vaginal swab, expanding the cobas platform’s sexual-health testing. The assay uses real-time PCR to identify bacteria and yeasts, including Gardnerella vaginalis, Atopobium vaginae, Lactobacillus species, and Candida species such as C. albicans and C. glabrata, providing a potentially more accurate diagnosis than traditional microscopy, pH testing, or clinical observation, which have high misdiagnosis rates. Roche emphasizes that accurate, timely results can help clinicians deliver the right treatment faster and may reduce recurrence. The test is designed for professional laboratory use and can be run alongside other sexual-health tests on the cobas 6800/8800 systems, enabling a broad-range, single-sample workflow. BV affects about 27% of women of reproductive age in North America, and up to 75% experience Candida vaginitis at least once, underscoring the public health relevance of improved diagnostic accuracy.